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Notice of Final Rule re Charging for Investigational Drugs Under an Investigational New Drug Application (US Food and Drug Administration Regulation) (FDA) (2018 Edition)

eBook details

Title: Notice of Final Rule re Charging for Investigational Drugs Under an Investigational New Drug Application (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
Author : The Law Library
Release Date : January 17, 2018
Genre: Law,Books,Professional & Technical,
Pages : * pages
Size : 282 KB

Description

The Law Library presents the complete text of the Notice of Final Rule re Charging for Investigational Drugs Under an Investigational New Drug Application (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency's final rule on expanded access for treatment use of investigational drugs published elsewhere in this issue of the Federal Register, and to clarify what costs can be recovered for an investigational drug. This final rule will permit charging for a broader range of uses than was explicitly permitted previously.

This ebook contains:
- The complete text of the Notice of Final Rule re Charging for Investigational Drugs Under an Investigational New Drug Application (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure